Schedule I & II Regulatory Verification Process

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1. Purpose

The purpose of this document is to describe the process that is implemented by the CFIA to verify that registered fish establishments are complying with the requirements of Schedule I & II of the Fish Inspection Regulations.

2. Scope

This process is part of the regulatory verification of all fish establishments registered under the authority of the Fish Inspection Regulations.

3. Process Description

3.1 Conducting the Inspection Task

The following describes the regulatory verification activities as applied to Schedule I & II in registered establishments:

a) Compliance Verification (CV)

A Schedule I & II inspection is a regulatory verification tool used by an inspector during a Compliance Verification (CV) that includes the establishment's Prerequisite Program Plan in the scope. For procedures in conducting compliance verifications see Chapter 3, Subject 3 of the Facilities Inspection Manual.

When the Reference Standard Element #3, Construction and Equipment, and/or Sanitation & Hygiene sections of the Pre-requisite Program Plan, is included in the Scope of a CV, the following must be conducted:

  • Construction and Equipment (sub-sections 3.1.1 to 3.1.4),
  • Sanitation and Personal Hygiene (sub-sections 3.1.1 to 3.1.4)
  • Pest Control (sub-sections 3.1.2 to 3.1.4).

In addition to assessing system controls of the Quality Management Program (QMP), a full inspection of the registered premises for compliance with Schedule I and Schedule II of the Fish Inspection Regulations, using the Facility Inspection Report and the Compliance and Assessment Guide for Schedule I & II of the Fish Inspection Regulations, will be conducted. Unless an issue is identified, it is not mandatory to include the Regulatory Action Point Plan (RAP) element and sections related to Ingredients and Packaging Material.

b) Conduct Schedule I & II Inspection Task

The Schedule I & II inspection task shall be conducted whenever the Prerequisite Program Plan (Element 3, Sections 1, 2 and 3) is included in the scope of a CV audit. The slice approach described in the Facilities Inspection Manual (Chapter 3, Subject 3, section 3.1) is not to be used to complete this task. This means that Schedule I & II inspections are to be conducted on the entire registered facility.

The Facility Inspection Report shall be completed and communicated to the establishment management as soon as possible. The resulting level of compliance shall be recorded as objective evidence in the CV along with any other objective evidence found during the CV as a result of other tasks such as observations, interviews, record reviews, etc.

The lowest level of compliance from the Schedule I and Schedule II assessment determines the overall level of compliance for the establishment. The level of compliance of the establishment will determine which of the following section(s) from Schedule I and Schedule II apply.

3.2 Results of the Inspection Task

3.2.1 Level of Compliance of "A" or "B"

A Schedule I & II inspection result of "A" or "B" is considered to be an acceptable level of compliance.

If the establishment has documented all deficiencies and has appropriate corrective actions in place, including the appropriate corrective action time lines, a non-conformity will not be issued.

If, however, the establishment has failed to identify some of the deficiencies, or if the corrective actions for deficiencies are not documented, not implemented, not effective or do not meet the time lines outlined below, a non-conformity may be issued.

Upon completion of the CV, an exit meeting will be conducted in accordance with the Facilities Inspection Manual, Chapter 3, Subject 3, section 3.12. If non-conformities have been identified in any element assessed, an acceptable Corrective Action Plan (CAP) must be submitted within 30 days of the exit meeting. All deficiencies and system fixes must be addressed within 30 days from the date an acceptable CAP is submitted. CFIA verification of the implementation and effectiveness of the CAP will occur at the next CV.

3.2.2 Level of Compliance of "C"

A Schedule I & II inspection result of "C" will be considered to be an unacceptable level of compliance and will result in a non conformity because the establishment failed to maintain compliance with Schedule I and/or II. A letter of non-compliance (i.e. warning letter) will be issued.

a) "C" Level of Compliance for Schedule I

When the level of compliance for Schedule I is assessed as "C", the CV continues as per regular procedures and the usual Corrective Action Process is followed. An acceptable CAP must be submitted within 30 days of the exit meeting. All deficiencies and system fixes must be addressed within 30 days from the date the acceptable CAP is submitted. Upon implementation of the CAP, the establishment must complete a Schedule I & II inspection of their facility and submit a completed Facility Self-Evaluation Report to the CFIA within this 30 day deadline. An unannounced CFIA verification of the implementation and effectiveness of the CAP may occur after the implementation deadline.

b) "C" Level of Compliance for Schedule II

When the level of compliance for Schedule II is assessed as "C", to continue operating, the establishment must correct enough deficiencies to attain a minimum of a "B" level of compliance within 3 days of receiving a completed Facility Inspection Report and/or a Notification of Non Compliance - PDF (100 kb) form. The establishment must provide the CFIA with the Facility Self-Evaluation Report which will indicate that the establishment is able to operate at this level of compliance while it works to correct any outstanding system and/or deficiency problems. An acceptable CAP must then be submitted within 30 days of the exit meeting. All deficiencies and system fixes must be addressed within 30 days from the date the acceptable CAP is submitted. Upon implementation of the CAP, the establishment must complete a Schedule I & II inspection of their facility and submit a completed Facility Self Evaluation Report to the CFIA within this 30 day deadline. Unannounced CFIA verification of the implementation and effectiveness of the CAP may occur after the implementation deadline.

If the establishment is not able to bring their Schedule II level of compliance to at least a "B" within the 3 day time line, they will have to either voluntarily cease operations (voluntary closure) or request an inactivation of their registration (see Section 3.3). If neither of these options is taken, the CFIA will initiate procedures to suspend the certificate of registration.

3.2.3 Level of Compliance of "D"

A Schedule I & II inspection result of "D" will be considered to be an unacceptable level of compliance and will result in a critical non conformity because the QMP Plan was ineffective in preventing conditions that could have, or has, resulted in contamination of the fish. The establishment will be notified in writing of the unacceptable inspection result with either a completed Facility Inspection Report and/or a Notification of Non Compliance - PDF (100 kb) form. All processing operations must stop and the processor must conduct a review to determine if the critical non-conformity may have affected product safety. Where there is any possibility that product safety may have been affected, the establishment must take immediate action as well as submit a written CAP within 24 hours documenting the results of their review and any product action taken or required.

The operator of the establishment will be given the opportunity to either voluntarily cease operations (voluntary closure) or request an inactivation their registration (see Section 3.3). If neither of these options is taken, the CFIA will initiate procedures to suspend the certificate of registration.

If a sufficient number of deficiencies can be immediately corrected, it may not be necessary to stop production. A critical non-conformity would still be issued but the establishment could continue operation as soon as the deficiencies have been corrected and verified by the inspector. The establishment must submit a written CAP within 24 hours documenting product action required or taken, the critical non-conformity fix, the system fix to prevent recurrence, any interim measures and all other requirements of the Corrective Action Process Standard. The CV process would then continue as per the regular Corrective Action Process Standard. An acceptable CAP dealing with any outstanding system and/or deficiency problems must be submitted within 30 days of the exit meeting. Those system and/or deficiency problems must be addressed within 30 days from the date an acceptable CAP is submitted. Upon implementation of the CAP, the establishment must complete a Schedule I & II inspection of their facility and submit a completed Facility Self-Evaluation Report to the CFIA within this 30 day deadline. An unannounced CFIA verification of the implementation and effectiveness of the CAP will occur as soon as possible after the implementation deadline.

Any time an unacceptable level of compliance is assessed a letter of non-compliance (i.e. a warning letter) will be issued.

3.3 Voluntary Closure or Inactivation

In some cases, an establishment may request:

  1. a voluntary closure where the minimum level of compliance (B) can be achieved in 5 calendar days or less, or
  2. an inactivation of the Certificate of Registration where a level of compliance (B) can not be achieved in 5 calendar days or less.

For establishments in voluntary closure and those in inactive status for less than 30 days, after enough deficiencies have been corrected to operate at the minimum level of compliance or better, an acceptable Facility Self-Evaluation Report must be submitted to the CFIA. If the establishment was in inactive status, an application for reactivation must also be submitted. After CFIA verification of the corrective action taken, the establishment will be permitted to resume operations and the CV activities will continue.

An acceptable CAP must then be submitted within 30 days of the exit meeting. All deficiencies and system fixes must be addressed with 30 days from the date an acceptable CAP is submitted. Upon implementation of the CAP, the establishment must complete a Schedule I & II inspection of their facility and submit a completed Facility Self-Evaluation Report to the CFIA within this 30 day deadline. Unannounced CFIA verification of the implementation and effectiveness of the CAP will occur after the implementation deadline.

If the establishment does not request reactivation within 30 days, an acceptable CAP for the identified deficiencies must still be submitted within 30 days of the inactivation date. Within 30 days of that CAP being accepted by the CFIA, a Facility Self-Evaluation Report documenting that an acceptable level of compliance has been attained must be submitted. If these requirements are not met, proceedings to suspend the certificate of registration may be initiated. If the requirements are met, the establishment must request reactivation before registration renewal. The establishment must be at an "A" or "B" level of compliance at that time and will be subject to a new CV.

3.4 Establishment is unwilling or unable to submit the Facility Self-Evaluation Report

If the establishment is unwilling or unable to submit the Facility Self-Evaluation Report, the inspector will verify the compliance level of the establishment by immediately conducting a complete, unannounced Schedule I and/or II inspection. If the establishment is found to not be at an acceptable level of compliance ("A" or "B") during this verification, or if any corrective actions were not implemented or not effective, the CFIA may initiate procedures to suspend the certificate of registration.

3.5 Corrective Actions

Corrective action plans are to be submitted as per the Corrective Action Process Standard.

3.6 CAP Implementation Extension Requests

CAP Implementation Extension requests may be approved on a case-by-case basis as per the Corrective Action Process Standard.

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